Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces that, on behalf of Santina Castriciano of Copan
Italia S.p.A. and in collaboration with Victorian Cytology Service
of the Australian Centre for the Prevention of Cervical Cancer (VCS
Pathology), it will present results of novel methods to support
diagnostic accuracy and whole-process workflow validation of
cervical cancer screening tests on self-collected patient
specimens. The poster presentation will be made at the 12th
European Meeting on Molecular Diagnostics (“
EMMD”)
taking place in Noordwijk, Netherlands from October 12 to 14, 2022.
Ample evidence supports use of self-collected
vaginal samples to improve participation in cervical cancer
screening programs based on molecular (“MDx”)
detection of Human Papilloma Virus (“HPV”).
However, broad adoption of self-collection has been set-back by a
lack of materials and methods to evaluate the whole workflow
experienced by a specimen – from collection to final diagnostic
result. This critical gap is bridged by the current study using
Microbix PROCEEDx™FLOQ® simulated positive HPV samples eluted into
Copan MSwab® medium – evaluating whether HPV was effectively eluted
from the simulated self-collected swabs and then detected by
commercial in vitro diagnostic (“IVD”) PCR-based
MDx assays.
The study determined that three positive
specimens simulating infection with high-risk HPV types (16, 18
& 45) and a negative sample were detected and individually
identified on six IVD MDx assays: the Abbott Alinity m HPV &
Abbott Realtime HPV, Qiagen NeumoDx HPV, Roche cobas 4800 HPV &
Roche cobas 6800 HPV, and Seegene Anyplex II HPV28. Accuracy was
100% across all sample types and assays. The poster will be
available on Microbix’s website (https://microbix.com) and from
EMMD after its presentation.
HPV represents a family of over 100 virus
sub-types, of which 14 are deemed “high-risk” as they are proven to
directly cause cancers, including but not limited to cervical
cancer. Most sexually-active adults become infected with one or
more types of HPV and such infections can be persistent. MDx tests
permit early detection and guide timely preventative healthcare by
identifying those at-risk years before the development of cancers.
However, MDx-based screening programs require rigorous workflow
design and ongoing validation to ensure their accuracy. Many
healthcare systems now plan to resume the roll-out of MDx-based HPV
screening programs that were delayed as a result of the COVID-19
pandemic, important diagnostic healthcare advancements that
Microbix is pleased to support with its products and services.
Empowering women to collect vaginal samples in
private, safe, and convenient locations is expected to promote
patient access to healthcare and accelerate the widespread adoption
of MDx-based HPV and cervical cancer screening programs. Microbix
is proud to be a strategic partner of Copan and help to accelerate
the evolution to self-collection by offering HPV-oriented
“PROCEED™FLOQ®” (RUO) and prospective
“REDx™FLOQ®” (IVD) quality assessment products
(QAPs™) worldwide. Purchase enquiries for Microbix’s QAPs can be
e-mailed to customer.service@microbix.com.About Microbix
BiosystemsMicrobix develops proprietary biological
products and services for human health and well-being, with over
100 skilled employees and sales approaching C$ 2.0 million per
month. It makes a wide range of critical ingredients and devices
for the global diagnostics industry, notably antigens for
immunoassays and its laboratory quality assessment products (QAPs™
IVD or RUO test-controls) that support clinical lab proficiency
testing, enable assay development and validation, or help ensure
the quality of clinical diagnostic workflows. Microbix antigens
enable the antibody tests of over 100 international diagnostics
companies, while its QAPs are sold to clinical laboratory
accreditation organizations, diagnostics companies, and clinical
laboratories. Microbix QAPs are now available in over 30 countries,
distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems,
Inc., Diagnostic International Distribution SpA., Labquality Oy,
The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular
Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. Microbix
is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian
TGA registered, Health Canada establishment licensed, and provides
CE marked products.
Microbix also applies its biological expertise
and infrastructure to develop other proprietary products and
technologies, most notably viral transport medium (DxTM™) to
stabilize patient samples for lab-based molecular diagnostic
testing and Kinlytic® urokinase, a biologic thrombolytic drug used
to treat blood clots. Microbix is traded on the TSX and OTCQX, and
headquartered in Mississauga, Ontario, Canada.
Forward-Looking InformationThis
news release includes “forward-looking information,” as such term
is defined in applicable securities laws. Forward-looking
information includes, without limitation, discussion of Copan, HPV,
EMMD, or VCS, the poster or its relevance, the products of Microbix
or its collaborators, Microbix’s business and business results,
goals or outlook, risks associated with financial results and
stability, development projects such as those referenced in its
corporate presentation, regulatory compliance and approvals, sales
to foreign jurisdictions, engineering and construction, production
(including control over costs, quality, quantity and timeliness of
delivery), foreign currency and exchange rates, maintaining
adequate working capital or raising further capital on acceptable
terms or at all, and other similar statements concerning
anticipated future events, conditions or results that are not
historical facts. These statements reflect management’s current
estimates, beliefs, intentions and expectations; they are not
guarantees of future performance. The Company cautions that all
forward-looking information is inherently uncertain, and that
actual performance may be affected by a number of material factors,
many of which are beyond the Company’s control. Accordingly, actual
future events, conditions and results may differ materially from
the estimates, beliefs, intentions and expectations expressed or
implied in the forward-looking information. All statements are made
as of the date of this news release and represent the Company’s
judgement as of the date of this new release, and the Company is
under no obligation to update or alter any forward-looking
information.
Please visit https://microbix.com or www.sedar.com
for recent Microbix news and filings.
For further information, please contact Microbix
at:
Cameron Groome, CEO(905) 361-8910 |
Jim Currie, CFO(905) 361-8910 |
Deborah Honig, Investor RelationsAdelaide Capital Markets(647)
203-8793 ir@microbix.com |
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Copyright © 2022 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, PROCEEDx™, QAPs™, REDx™ and REDx™
Controls are trademarks of Microbix Biosystems Inc.PROCEEDx™FLOQ®
and REDx™FLOQ® are trademarks of Microbix Biosystems Inc. in
collaboration with Copan Italia S.p.A.Copan®, FLOQ®, FLOQSwab®, and
MSwab® are trademarks of Copan Italia S.p.A.Other parties’
corporate or product names referenced herein may be the trademarks
of their respective companies.
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